BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP

    MDR report key: 9355444 · Received November 21, 2019

    Report

    Report Number
    3002682307-2019-00617
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903058914
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 305891 LOT 1905013 TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD UNDERSTANDS THE LEAKAGE COULD HAVE TAKEN PLACE BECAUSE OF A DEFECTIVE HUB CONNECTION BECAUSE OF A CONNECTIVITY ISSUE LINKED TO INCORRECT LUER DIMENSIONS OR ANY DAMAGE IN THE SYRINGE TIP. IT MAY ALSO BE RELATED TO THE HANDLING OF THE PRODUCT AS SOME ADJUSTMENT BETWEEN THE DEVICES BY THE END USER. AS THIS IS THE FIRST TIME THIS LOT HAS BEEN REPORTED FOR THIS DEFECT AND THE DEVICE HISTORY REVIEW SHOWS NO ABNORMALITIES DURING THE NEEDLE MANUFACTURING PROCESS, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 25 G X 1 IN. ECLIPSE NEEDLES SMARTSLIP EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO INFORM YOU ABOUT THE APPLICATION OF THE VAXIGRIP TETRA 2019/2020 INFLUENZA VACCINE IN USE WITH BD ECLIPSE NEEDLES AND A POSSIBLE SYSTEM LEAKAGE DURING THE ADMINISTRATION OF THE VACCINE. IN OUR COMPANY MEDICAL OUTPATIENT DEPARTMENT, THERE WERE REPEATED INCIDENTS THAT THE SYSTEM DID NOT CLOSE TIGHTLY AND VACCINE EMERGED DURING ADMINISTRATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 25 G X 1 IN. ECLIPSE NEEDLES SMARTSLIP EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO INFORM YOU ABOUT THE APPLICATION OF THE VAXIGRIP TETRA 2019/2020 INFLUENZA VACCINE IN USE WITH BD ECLIPSE NEEDLES AND A POSSIBLE SYSTEM LEAKAGE DURING THE ADMINISTRATION OF THE VACCINE. IN OUR COMPANY MEDICAL OUTPATIENT DEPARTMENT, THERE WERE REPEATED INCIDENTS THAT THE SYSTEM DID NOT CLOSE TIGHTLY AND VACCINE EMERGED DURING ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153985 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1905013 00382903058914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other